Alzheimer's Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Phase 1b Safety Study of Three Different Doses of an Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) or Placebo in Patients With Mild to Moderate Probable Alzheimer's Disease
This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI [acetylcholinesterase inhibitor]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.
This is a randomized, double-blind, placebo-controlled, Phase 1b safety study of three dose
levels of EVP-6124 in subjects with mild or moderate Alzheimer's disease and who are taking
an AChEI medication (donepezil or rivastigmine).
Study drug will be supplied as capsules and will be orally administered once daily for a
total of 28 days. Eligible subjects will be admitted to an inpatient study unit on Day -2
(two days before the first dose of study drug is administered) and will remain confined to
the inpatient study unit for a total of five days. Starting on Day 4, subjects will continue
the study in the outpatient setting, with study visits on Days 7, 14, 21, and 28. Safety
assessments, PK sampling, and cognitive testing will be performed inpatient and at each
study visit.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Withdrawn |
NCT03316898 -
A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease
|
Phase 1 | |
| Withdrawn |
NCT02860065 -
CPC-201 Alzheimer's Disease Type Dementia: PET Study
|
Phase 2 | |
| Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
| Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
| Recruiting |
NCT05607615 -
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
|
Phase 2 | |
| Terminated |
NCT03307993 -
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
|
Phase 1 | |
| Recruiting |
NCT02912936 -
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
|
N/A | |
| Active, not recruiting |
NCT02899091 -
Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02907567 -
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT02868905 -
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
|
N/A | |
| Completed |
NCT02516046 -
18F-AV-1451 Autopsy Study
|
Phase 3 | |
| Completed |
NCT02580305 -
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
|
Phase 2 | |
| Terminated |
NCT02521558 -
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
|
N/A | |
| Recruiting |
NCT02247180 -
Cognitive Rehabilitation in Alzheimer`s Disease
|
N/A | |
| Completed |
NCT02260167 -
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
|
N/A | |
| Terminated |
NCT02220738 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
|
Phase 1 | |
| Completed |
NCT02256306 -
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
|
N/A | |
| Completed |
NCT02317523 -
Alzheimer's Caregiver Coping: Mental and Physical Health
|
N/A | |
| Completed |
NCT02094729 -
A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's Disease
|
Phase 1 |